Over-the-counter weed to help with sleep still a dream, as clinical trials fail

Insomniacs dreaming of obtaining marijuana in a pharmacy without a prescription to help them sleep will have to keep waiting, as several clinical trials have failed to prove its effectiveness.

Australia has one of the fastest-growing medical cannabis markets in the world despite authorities approving almost zero cannabis medicines, except some primarily prescribed for pain.

To fix that, government regulators in 2020 offered the medical marijuana industry a deal: if they can prove a low-dose cannabis drug works in a clinical trial, they can sell it over the counter at the nation’s 5000-plus pharmacies, opening a potentially enormous market.

Dr Paul Gavin, Avecho CEO, is a cannabis medicine developer and also a critic of the industry.Credit: Joe Armao

Companies and researchers immediately launched trials targeting sleep, buoyed by self-reported data from cannabis users who widely claim the drug improves their slumber.

So far, none of those trials have met their primary success criteria. Bod Science became the latest when last week it informed the stockmarket its drug had failed to beat a placebo on a standard measure of treatment success.

For years, cannabis advocates have claimed research would eventually reveal the drug is a powerful medicine. Despite several years of legalisation, that has not quite happened.

“It’s certainly not as good as everyone expected it to be, it’s not a blockbuster,” said Professor Jennifer Martin, a cannabis researcher and chair of clinical pharmacology at the University of Newcastle.

“It may help some people with some symptoms some of the time. For most conditions, more benefit than placebo has not been objectively shown.”

Dried cannabis flower is a steadily-growing component of the industry.Credit: Janie Barrett

In 2020, drug regulator the Therapeutic Goods Administration announced it would allow low-dose CBD products to be sold over-the-counter providing the industry could prove they worked as medicines.

There are currently only two medicinal cannabis products registered for use in Australia: Sativex for patients with multiple sclerosis, while Epidyolex is used for the management of Dravet and Lennox-Gastaut syndromes.

“They want to drag the medicinal cannabis industry into regulation,” said Dr Paul Gavin, CEO of Avecho Biotechnology, a company developing its own low-dose CBD product.

CBD is one of the main compounds of cannabis under investigation for therapeutic properties. It is not psychoactive — low-dose CBD products are available without a prescription in the United States and Europe where regulators view them as very safe.

But safe is not the same as effective. There remains no high-quality evidence showing low-dose CBD has any medical effects.

Cann Group’s trial of Satipharm failed to beat placebo in trial data published in January; EcoFibre’s trial failed about the same time. A small Swinburne University-led trial failed in late 2022.

Clinical trials have yet to prove medical marijuana’s effectiveness for sleep.Credit: AP

The industry and researchers have different perspectives on what has gone wrong.

Bod Science CEO Jo Patterson argues that slicing the data in a different way shows their drug did beat a placebo. The company plans to submit it to the regulator for approval. “We’ve proven efficacy of the indication we were looking at,” she said.

Two other researchers, granted anonymity to discuss the results, disagreed. “It is not good practice to ignore the primary endpoint and analysis for another one that looks more supportive [of] treatment after the results are out,” said one.

Proving a drug improves sleep is “notoriously difficult”, says Cann Group CEO Peter Koetsier. Sleep quality is very subjective. And placebos tend to help with insomnia dramatically – making it hard to prove a drug works better.

“Essentially, you were getting massive sleep improvements across the board,” Koetsier said.

Beating a placebo may require a more powerful drug, says Avecho’s Paul Gavin. He points to Bod’s trial showing a signal for effectiveness at a higher dose, and his company has developed a formulation to make low-dose CBD more bioavailable.

Their trial will be more than twice as large as Bod’s, increasing their ability to detect real effects.

Gavin believes cannabis will eventually be proven as a medicine: “100 per cent they will. It’s just going to take us a lot of money.”

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